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PHYTEX PAINT CUTANEOUS SOLUTION

Active substance(s): BORIC ACID / METHYL SALICYLATE / SALICYLIC ACID / TANNIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Phytex Paint Cutaneous Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution contains tannic acid 4.886% w/v, boric acid 3.1245 w/v, salicylates
(as salicylic acid 0.89% w/v and methyl salicylate 0.526% v/v).

3

PHARMACEUTICAL FORM
A clear, pale straw-coloured cutaneous solution for application to skin and
nails.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of infections of the skin and nails due to superficial
dermatophytes of Candida.

4.2

Posology and method of administration
For adults, including the elderly, and children over five years:
The tincture is painted onto the affected areas morning and evening and after
washing. Several weeks of treatment may be required to prevent relapse.
Children under five years: Contraindicated.

4.3

Contraindications

Known sensitivity to any of the ingredients. Do not use in children under five.
Should not be used on broken or inflamed skin, Use in pregnancy.

4.4

Special warnings and precautions for use
Do not use for longer than 10 days without consulting a doctor. For use on nail
areas and feet only. Phytex should be used with caution in patients with
impaired circulation and diabetics. Phytex is for topical use only and may be
harmful if taken internally.

4.5

Interaction with other medicinal products and other forms of interaction
None stated.

4.6

Pregnancy and lactation
Contraindicated

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Slight stinging may occur on application. Any further discomfort caused by
dryness of the skin may be due to the astringent nature of the product.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Borotannic complex possesses bacteriostatic and fungistatic properties. After
application the solvent evaporates to leave a clear film over the infected area.
Perspiration subsequently dissolves the active complex which ionises
producing a low pH (about 2.0) that is fungicidal. Salicylic acid facilitates
penetration of infected skin.

5.2

Pharmacokinetic properties
Salicytic acid and methyl salicylate are absorbed through the skin, however,
the quantities present in Phytex would make the possibility of systemic
salicylate poisoning remote. Unbound boric acid or Tannic acid may be
absorbed through damaged skin. The quantities present in Phytex would
indicate that systemic effects are highly unlikely.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glacial acetic acid
Industrial methylated spirit
Ethyl acetate

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Three years

6.4

Special precautions for storage
Do not store above 25 C. Keep bottle firmly closed.

6.5

Nature and contents of container
Amber glass bottle with polypropylene screw cap and applicator brush,
containing 25 ml.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
QP-services UK Ltd
Office B, 57 High Street
Yatton

Somerset
BS49 4EQ
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 29498/0005

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23 March 1984/28 June 2011

10

DATE OF REVISION OF THE TEXT
28 June 2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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